The primary endpoint was metastasis free survival ( MFS ), defined as the time from randomization to first evidence of distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first.
The median MFS was 40.4 months ( 95% CI: 34.3, not reached ) for patients treated with Darolutamide compared with 18.4 months ( 95% CI: 15.5, 22.3 ) for those receiving placebo ( hazard ratio, HR=0.41; 95% CI: 0.34, 0.50; p less than 0.0001 ).
Overall survival ( OS ) data were not mature.

The most common adverse reactions ( greater than or equal to 2% ) in patients who received Darolutamide were fatigue, pain in extremity, and rash.
Ischemic heart disease ( 4.3% ) and heart failure ( 2.1% ) were more common on the Darolutamide arm.
The seizure incidence was similar on the two arms ( 0.2% ).